Personalized Nutrition Intervention for Gestational Diabetes

(DESI-GDM Trial)

Not currently recruiting at 1 trial location

Overseen By Farah Khan, MBBS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Type 1 or 2 diabetes, Hypertension, Poor English, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a personalized nutrition plan for pregnant women of South Asian ancestry at risk of gestational diabetes. The goal is to determine if a diet tailored to cultural and personal preferences can manage blood sugar levels, benefiting both mother and baby. Participants will either receive a culturally-tailored personalized nutrition intervention, which includes a customized diet plan, guidance from a health coach, and a Fitbit to track activity, or they will receive general advice and text reminders to encourage walking. Ideal candidates are South Asian women, 12-18 weeks pregnant, with factors such as a family history of diabetes or previous gestational diabetes. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve health outcomes for mothers and babies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this personalized nutrition intervention is safe for high-risk pregnancies?

Research has shown that a nutrition plan tailored to individual and cultural needs can be safe and easy to follow. In a study with 215 women who had gestational diabetes, specific nutrition guidelines reduced the need for insulin and improved overall health. This plan respects personal and cultural food preferences, offering flexibility while aiming to boost health without negative effects. Studies indicate that most participants find this type of plan acceptable and manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for gestational diabetes focus on medication or general dietary guidelines. However, the Personalized Nutrition Intervention is unique because it tailors nutrition plans to individual preferences, including cultural and faith-based food choices. This approach is exciting because it offers a more personalized method by setting specific "SMART" goals and using culturally congruent health coaches. Additionally, participants receive supportive text messages and tools like Fitbits to encourage healthier lifestyle habits, making it a holistic and community-sensitive strategy. Researchers hope this will lead to better adherence and outcomes for diverse populations.

What evidence suggests that this personalized nutrition intervention might be effective for gestational diabetes?

Research has shown that nutrition plans tailored to cultural food preferences can help manage blood sugar levels in individuals at risk of gestational diabetes. In this trial, participants in the Dietary Intervention arm will receive personalized plans crafted by health coaches familiar with their cultural backgrounds. Early results suggest these plans can enhance the body's ability to process sugar, crucial for pregnant women at risk of gestational diabetes. By setting clear and achievable health goals, this approach supports the mother's health and may also benefit the baby's future health. Overall, adapting nutrition to cultural needs appears promising in effectively managing gestational diabetes. ^{1 2 3 6 7}

Who Is on the Research Team?

Russell J de Souza, ScD

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

This trial is for South Asian women between 12-18 weeks pregnant, at risk of gestational diabetes due to factors like age over 29, poor diet, family history of diabetes, or previous gestational diabetes. They must have a single pregnancy and be willing to modify their diet.

Inclusion Criteria

You are pregnant with only one baby.

I am over 29, have a poor diet, a family history of diabetes, had gestational diabetes, or my BMI is over 23.17.

You are currently pregnant and have ancestors from South Asia.

Exclusion Criteria

I often feel very nauseous or vomit a lot.

I am not willing to change my diet.

You have a higher chance of having complications during pregnancy, like having twins, using fertility treatments, or having certain health conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a culturally-tailored personalized nutrition intervention delivered by a trained health coach, including a personalized nutrition plan, text messages, and a Fitbit for tracking steps.

3 months

Weekly text messages, regular coaching contacts

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of gestational diabetes mellitus and maternal blood pressure.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Culturally-tailored Personalized Nutrition Intervention

Trial Overview The study tests a personalized nutrition plan tailored to cultural preferences against a control group with standard advice. It aims to see if the special diet can improve blood sugar levels after an oral glucose test in both mother and infant.

How Is the Trial Designed?

Group I: Dietary Intervention Experimental Treatment 1 Intervention

A personalized nutrition plan will be developed for each woman and will respect faith-based food choices and regional preferences. The plan will be delivered by a culturally congruent health coach, and consider baseline dietary intake, energy balance for recommended gestational weight gain, personal values and preferences, through setting 2-4 "SMART" goals. Participants assigned to the intervention group will receive text messages. Participants assigned to the intervention group will be given a Fitbit to track their steps and will receive simple text messages weekly, aimed at increasing walking. They will be given PDF resources that provide advice on healthy eating, physical activity, and other lifestyle factors during pregnancy plus additional materials adapted specifically for the South Asian community.

Group II: Control Active Control 1 Intervention

Participants in the control group will receive simple text messages weekly, aimed at increasing walking. They will be given PDF resources that provide advice on healthy eating, physical activity, and other lifestyle factors during pregnancy plus additional materials adapted specifically for the South Asian community.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Hamilton Health Sciences Corporation

Collaborator

Trials

380

Recruited

345,000+

Population Health Research Institute

Collaborator

Trials

165

Recruited

717,000+

Published Research Related to This Trial

A study involving 180 gestational diabetes mellitus (GDM) patients showed that interdisciplinary health education combined with personalized nutrition significantly reduced fasting blood glucose (FPG), two-hour postprandial glucose (2hPBG), and glycated hemoglobin (HbA1C) levels compared to routine care.

The intervention also led to improved psychological scores (SDS and SAS) after treatment, indicating better overall management of GDM, although the difference in pregnancy outcomes between the two groups was not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of interdisciplinary and diversified health education combined with personalized nutrition intervention on FPG, 2hPG, SDS, SAS scores and the pregnancy outcomes of gestational diabetes mellitus. Zhu, GH., Xu, Y., Zou, L., et al.[2021]

A group-based lifestyle modification program for women with previous gestational diabetes showed some improvement in dietary quality, particularly in dairy consumption, but overall diet quality remained low after 12 months.

While the intervention group reduced alcohol intake by 2% and improved dairy scores, the total Australian Recommended Food Score (ARFS) did not significantly change, indicating a need for more effective strategies to enhance dietary quality in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a diabetes prevention program on dietary quality in women with previous gestational diabetes. O'Reilly, S., Versace, V., Mohebbi, M., et al.[2020]

A scoping review of 12 studies on nutrition-education interventions for gestational diabetes showed that both general and personalized nutrition strategies can effectively manage high blood sugar levels during pregnancy.

The review highlighted that while diabetes self-management education varied in content, medical nutrition therapy was more consistent, indicating a need for standardized approaches in nutrition education for gestational diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition-Education-Based Interventions in Gestational Diabetes: A Scoping Review of Clinical Trials. Helm, MM., Izuora, K., Basu, A.[2023]

A clinical trial involving 215 women with gestational diabetes showed that following specific nutrition practice guidelines led to less insulin use and better control of glycated hemoglobin levels in diabetes clinic settings compared to usual care.

Women receiving care under the nutrition practice guidelines had a lower proportion of elevated glycated hemoglobin levels (8.1%) compared to those in the usual care group (13.6%), suggesting that these guidelines may improve management of gestational diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of gestational diabetes mellitus nutrition practice guidelines implemented by registered dietitians on pregnancy outcomes. Reader, D., Splett, P., Gunderson, EP.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37130668/

A culturally tailored personaliseD nutrition intErvention in ... Our study seeks to evaluate the effectiveness and participant acceptability of a culturally tailored, personalised nutrition intervention on the glucose area ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03607799

A Culturally-tailored Personalized Nutrition Intervention in ... This trial will assess the impact of a culturally tailored, personalized nutrition intervention on glycemic response to an oral glucose load (as measured by ...

3. bmjopen.bmj.com bmjopen.bmj.com/content/13/5/e072353

A culturally tailored personaliseD nutrition intErvention in ... Our study seeks to evaluate the effectiveness and participant acceptability of a culturally tailored, personalised nutrition intervention on the glucose area ...

4. clinicaltrial.be clinicaltrial.be/en/details/67879?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

A Culturally-tailored Personalized Nutrition Intervention... The DESI-GDM study is a randomized study to assess the impact of a culturally tailored, personalized nutrition intervention on glycemic ...

5. diabetes.jmir.org diabetes.jmir.org/2024/1/e58327

Personalized and Culturally Tailored Features of Mobile Apps ... This scoping review aims to explore the extent to which published studies report the integration and effectiveness of personalized and culturally tailored ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11683422/

Personalized and Culturally Tailored Features of Mobile ... Evaluating the effects of mobile health intervention on weight management, glycemic control and pregnancy outcomes in patients with gestational diabetes ...

7. withpower.com withpower.com/trial/phase-diabetes-mellitus-2-2019-783da

Personalized Nutrition Intervention for Gestational ... A clinical trial involving 215 women with gestational diabetes showed that following specific nutrition practice guidelines led to less insulin use and better ...